HealthyPhase 1NCT03694041
Safety, Tolerability, PK and PD of SAD or MAD of APX-115 in Healthy Male Volunteers
A Phase 1 study testing SAD: APX-115, MAD: APX-115 and Food effect: fasted and fed in people with Healthy and Safety, run by Aptabio Therapeutics, Inc. at 1 site in France.
Trial summary
This study aims to evaluate the safety, tolerabilty, pharmacokinetics and pharmacodynamics of single ascending doses and multiple ascending doses of APX-115 in healthy males. This study also aims to evaluate the effect of food consumption on the pharmacokinetics of APX-115 and potential interaction between caffeine… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- What is being tested?
- SAD: APX-115, MAD: APX-115 and Food effect: fasted and fed
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 28 May 2018to 6 Mar 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subject, aged between 18 and 45 years inclusive
- Certified as healthy by a comprehensive clinical assessment
- Normal dietary habits
- Normal ECG recording on a 12-lead ECG
- Signing a written informed consent prior to selection
Who cannot join
- Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, infectious or ocular disease
- Frequent headaches and / or migraine, recurrent nausea and / or vomiting
- Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20 mmHg within two minutes when changing from the supine to the standing position
- Blood donation (including in the frame of a clinical trial) within 2 months before administration
- General anaesthesia within 3 months before administration
- Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician
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- Inability to abstain from intensive muscular effort
- No possibility of contact in case of emergency
- Any drug intake (except paracetamol or contraception) during the last month prior to the first administration
- History or presence of drug or alcohol abuse (alcohol consumption > 30 grams / day)
- Excessive consumption of beverages with xanthine bases (> 4 cups or glasses / day)
- Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests
- Positive results of screening for drugs of abuse
- Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development
- Administrative or legal supervision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blind, Randomized Study Assessing the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses or Multiple Ascending Doses of APX-115 in Healthy Male Volunteers.
This study aims to evaluate the safety, tolerabilty, pharmacokinetics and pharmacodynamics of single ascending doses and multiple ascending doses of APX-115 in healthy males. This study also aims to evaluate the effect of food consumption on the pharmacokinetics of APX-115 and potential interaction between caffeine and APX-115 in healthy males.
- Being tested
- SAD: APX-115, SAD: Placebo, MAD: APX-115, MAD: Placebo, Food effect: fasted and fed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAD: APX-115Drug
Drug: APX-115 SAD APX-115 SAD for 1day
SAD: PlaceboDrug
Drug: Placebo Placebo for 1day
MAD: APX-115Drug
Drug: APX-115 MAD APX-115 MAD repeatedly administered.
MAD: PlaceboDrug
Matching study drug will be repeatedly administered.
Food effect: fasted and fedOther
A single dose of APX-115, selected from the SAD study, will be administered under fasted and fed condition.
Metabolic probe with or without APX-115Other
A metabolic probe will be administered with and without APX-115.
| Study group | Role | What they receive |
|---|---|---|
| SAD: APX-115 | Experimental | Experimental: APX-115 SAD group Receives: Drug: SAD: APX-115 |
| SAD: Placebo | Placebo comparator | Experimental: Placebo group Receives: Drug: SAD: Placebo |
| MAD: APX-115 | Experimental | Experimental: APX-115 MAD group Receives: Drug: MAD: APX-115 |
| MAD: Placebo | Placebo comparator | Experimental: Placebo group Receives: Drug: MAD: Placebo |
| Food effect - Fasting condition | Active comparator | Experimental: APX-115 under fasting condition Receives: Other: Food effect: fasted and fed |
| Food effect - fed condition | Active comparator | Experimental: APX-115 under fed condition Receives: Other: Food effect: fasted and fed |
| Drug Interaction - metabolic probe | Placebo comparator | Experimental: metabolic probe Receives: Other: Metabolic probe with or without APX-115 |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAD: incidence of treatment emergent adverse events
Measured: Up to Day 8
SAD: number of clinically significant abnormal findings from vital signs (blood pressure, pulse)
Measured: Up to Day 8
SAD: number of clinically significant abnormal findings from physical exam
Measured: Up to Day 8
SAD: number of clinically significant abnormal findings from electrocardiogram
Measured: Up to Day 8
SAD: number of clinically significant abnormal findings from biological tests
Measured: Up to Day 8
MAD: incidence of treatment emergent adverse events
Measured: Up to Day 17
MAD: number of clinically significant abnormal findings from vital signs (blood pressure, pulse)
Measured: Up to Day 17
MAD: number of clinically significant abnormal findings from physical exams
Measured: Up to Day 17
MAD: number of clinically significant abnormal findings from electrocardiogram
Measured: Up to Day 17
Food effect: peak serum concentration (Cmax) of APX-115 under fasting and fed conditions
Measured: Up to Day 4 post-dose
Food effect: time to reach the Cmax (Tmax) of APX-115 under fasting and fed conditions
Measured: Up to Day 4 post-dose
Food effect: area under the curve (AUC) of APX-115 under fasting and fed conditions
Measured: Up to Day 4 post-dose
Food effect: elimination rate constant (Kel) of APX-115 under fasting and fed conditions
Measured: Up to Day 4 post-dose
Food effect: ratio AUCfed/AUCfasted
Measured: Up to Day 4 post-dose
Drug interaction: peak serum concentration (Cmax) of a metabolic probe or APX-115
Measured: Up to Day 4 post-dose
Drug interaction: Time to reach the Cmax (tmax) of a metabolic probe or APX-115
Measured: Up to Day 4 post-dose
Drug interaction study: Area under the Curve (AUC) of a metabolic probe or APX-115
Measured: Up to Day 4 post-dose
Drug interaction: elimination rate constant (Kel) of a metabolic probe or APX-115
Measured: Up to Day 4 post-dose
Drug interaction: half-life (t1/2) of a metabolic probe or APX-115
Measured: Up to Day 4 post-dose
Drug interaction: volume of distribution (Vd/f) of a metabolic probe or APX-115
Measured: Up to Day 4 post-dose
Drug interaction: clearance of a metabolic probe or APX-115
Measured: Up to Day 4 post-dose
Drug interaction: Incidences of treatment emergent adverse events
Measured: Up to Day 4 post-dose
Secondary outcomes (18)
SAD: time to reach Cmax (Tmax) of APX-115
Measured: Up to Day 5
SAD: peak serum concentration (Cmax) of APX-115
Measured: Up to Day 5
SAD: lowest plasma concentration before next dosing (Ctrough)
Measured: Up to Day 5
SAD: Area Under the Curve (AUC) of APX-115
Measured: Up to Day 5
SAD: volume of distribution (Vd/F) of APX-115
Measured: Up to Day 5
SAD: clearance (CL/F) of APX-115
Measured: Up to Day 5
MAD: peak serum concentration (Cmax) of APX-115
Measured: Up to Day 11
MAD: time to reach the Cmax (Tmax) of APX-115
Measured: Up to Day 11
MAD: Area Under the Curve (AUC) of APX-115
Measured: Up to Day 11
MAD: lowest plasma concentration of APX-115 before next dosing (Ctrough)
Measured: Up to Day 11
MAD: volume of distribution (Vd/F) of APX-115
Measured: Up to Day 11
MAD: Clearance (CL/F) of APX-115
Measured: Up to Day 11
MAD: accumulation ratio
Measured: Up to Day 11
Food effect & drug interaction: incidence of treatment emergent adverse events
Measured: Up to Day 4 post-dose
Food effect & drug interaction: number of clinically significant findings from vital signs (blood pressure and pulse)
Measured: Up to Day 4 post-dose
Food effect & drug interaction: number of clinically significant findings from physical exam
Measured: Up to Day 4 post-dose
Food effect & drug interaction: number of clinically significant findings from electrocardiogram
Measured: Up to Day 4 post-dose
Food effect & drug interaction: number of clinically significant findings from biological tests
Measured: Up to Day 4 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start28 May 2018
- Primary completion6 Mar 2019
- Study completion6 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel design for SAD and MAD studies Crossover design for Food and Drug interaction studies
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aptabio Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yves Donazzolo, MD, Principal investigator, Eurofins Optimed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694041
- Sponsor's protocol ID
- OP101817.APT
- Other IDs
- 2017-004252-30, 2017
- Status last verified
- Mar 2019
- First submitted
- 20 Sep 2018
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Randomized Study Assessing the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses or Multiple Ascending Doses of APX-115 in Healthy Male Volunteers.
- ClinicalTrials.gov ID
- NCT03694041
- Acronym / sponsor ID
- OP101817.APT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Aptabio Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 May 2018 (actual)
- Primary completion
- 6 Mar 2019 (actual)
- Study completion
- 6 Mar 2019 (actual)
- First posted
- 3 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the safety, tolerabilty, pharmacokinetics and pharmacodynamics of single ascending doses and multiple ascending doses of APX-115 in healthy males. This study also aims to evaluate the effect of food consumption on the pharmacokinetics of APX-115 and potential interaction between caffeine and APX-115 in healthy males.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
- Model description
- Parallel design for SAD and MAD studies Crossover design for Food and Drug interaction studies
| Arm | Type | Receives |
|---|---|---|
| SAD: APX-115 | Experimental | Drug: SAD: APX-115Experimental: APX-115 SAD group |
| SAD: Placebo | Placebo comparator | Drug: SAD: PlaceboExperimental: Placebo group |
| MAD: APX-115 | Experimental | Drug: MAD: APX-115Experimental: APX-115 MAD group |
| MAD: Placebo | Placebo comparator | Drug: MAD: PlaceboExperimental: Placebo group |
| Food effect - Fasting condition | Active comparator | Other: Food effect: fasted and fedExperimental: APX-115 under fasting condition |
| Food effect - fed condition | Active comparator | Other: Food effect: fasted and fedExperimental: APX-115 under fed condition |
| Drug Interaction - metabolic probe | Placebo comparator | Other: Metabolic probe with or without APX-115Experimental: metabolic probe |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male subject, aged between 18 and 45 years inclusive
- Certified as healthy by a comprehensive clinical assessment
- Normal dietary habits
- Normal ECG recording on a 12-lead ECG
- Signing a written informed consent prior to selection
Key exclusion criteria (15 listed)
- Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, infectious or ocular disease
- Frequent headaches and / or migraine, recurrent nausea and / or vomiting
- Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20 mmHg within two minutes when changing from the supine to the standing position
- Blood donation (including in the frame of a clinical trial) within 2 months before administration
- General anaesthesia within 3 months before administration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAD: APX-115Drug: APX-115 SAD APX-115 SAD for 1day | Drug | SAD: APX-115 |
| SAD: PlaceboDrug: Placebo Placebo for 1day | Drug | SAD: Placebo |
| MAD: APX-115Drug: APX-115 MAD APX-115 MAD repeatedly administered. | Drug | MAD: APX-115 |
| MAD: PlaceboMatching study drug will be repeatedly administered. | Drug | MAD: Placebo |
| Food effect: fasted and fedA single dose of APX-115, selected from the SAD study, will be administered under fasted and fed condition. | Other | Food effect - Fasting condition, Food effect - fed condition |
| Metabolic probe with or without APX-115A metabolic probe will be administered with and without APX-115. | Other | Drug Interaction - metabolic probe |
Primary outcome
SAD: incidence of treatment emergent adverse events
Time frame: Up to Day 8
SAD: number of clinically significant abnormal findings from vital signs (blood pressure, pulse)
Time frame: Up to Day 8
SAD: number of clinically significant abnormal findings from physical exam
Time frame: Up to Day 8
SAD: number of clinically significant abnormal findings from electrocardiogram
Time frame: Up to Day 8
SAD: number of clinically significant abnormal findings from biological tests
Time frame: Up to Day 8
MAD: incidence of treatment emergent adverse events
Time frame: Up to Day 17
MAD: number of clinically significant abnormal findings from vital signs (blood pressure, pulse)
Time frame: Up to Day 17
MAD: number of clinically significant abnormal findings from physical exams
Time frame: Up to Day 17
MAD: number of clinically significant abnormal findings from electrocardiogram
Time frame: Up to Day 17
Food effect: peak serum concentration (Cmax) of APX-115 under fasting and fed conditions
Time frame: Up to Day 4 post-dose
Food effect: time to reach the Cmax (Tmax) of APX-115 under fasting and fed conditions
Time frame: Up to Day 4 post-dose
Food effect: area under the curve (AUC) of APX-115 under fasting and fed conditions
Time frame: Up to Day 4 post-dose
Food effect: elimination rate constant (Kel) of APX-115 under fasting and fed conditions
Time frame: Up to Day 4 post-dose
Food effect: ratio AUCfed/AUCfasted
Time frame: Up to Day 4 post-dose
Drug interaction: peak serum concentration (Cmax) of a metabolic probe or APX-115
Time frame: Up to Day 4 post-dose
Drug interaction: Time to reach the Cmax (tmax) of a metabolic probe or APX-115
Time frame: Up to Day 4 post-dose
Drug interaction study: Area under the Curve (AUC) of a metabolic probe or APX-115
Time frame: Up to Day 4 post-dose
Drug interaction: elimination rate constant (Kel) of a metabolic probe or APX-115
Time frame: Up to Day 4 post-dose
Drug interaction: half-life (t1/2) of a metabolic probe or APX-115
Time frame: Up to Day 4 post-dose
Drug interaction: volume of distribution (Vd/f) of a metabolic probe or APX-115
Time frame: Up to Day 4 post-dose
Drug interaction: clearance of a metabolic probe or APX-115
Time frame: Up to Day 4 post-dose
Drug interaction: Incidences of treatment emergent adverse events
Time frame: Up to Day 4 post-dose
18 secondary outcomes
SAD: time to reach Cmax (Tmax) of APX-115
Time frame: Up to Day 5
SAD: peak serum concentration (Cmax) of APX-115
Time frame: Up to Day 5
SAD: lowest plasma concentration before next dosing (Ctrough)
Time frame: Up to Day 5
SAD: Area Under the Curve (AUC) of APX-115
Time frame: Up to Day 5
SAD: volume of distribution (Vd/F) of APX-115
Time frame: Up to Day 5
SAD: clearance (CL/F) of APX-115
Time frame: Up to Day 5
MAD: peak serum concentration (Cmax) of APX-115
Time frame: Up to Day 11
MAD: time to reach the Cmax (Tmax) of APX-115
Time frame: Up to Day 11
MAD: Area Under the Curve (AUC) of APX-115
Time frame: Up to Day 11
MAD: lowest plasma concentration of APX-115 before next dosing (Ctrough)
Time frame: Up to Day 11
MAD: volume of distribution (Vd/F) of APX-115
Time frame: Up to Day 11
MAD: Clearance (CL/F) of APX-115
Time frame: Up to Day 11
MAD: accumulation ratio
Time frame: Up to Day 11
Food effect & drug interaction: incidence of treatment emergent adverse events
Time frame: Up to Day 4 post-dose
Food effect & drug interaction: number of clinically significant findings from vital signs (blood pressure and pulse)
Time frame: Up to Day 4 post-dose
Food effect & drug interaction: number of clinically significant findings from physical exam
Time frame: Up to Day 4 post-dose
Food effect & drug interaction: number of clinically significant findings from electrocardiogram
Time frame: Up to Day 4 post-dose
Food effect & drug interaction: number of clinically significant findings from biological tests
Time frame: Up to Day 4 post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves Donazzolo, MD principal investigator
Eurofins Optimed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SAD: APX-115, MAD: APX-115 and Food effect: fasted and fed in people with Healthy and Safety, run by Aptabio Therapeutics, Inc. at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAD: incidence of treatment emergent adverse events (time frame: Up to Day 8). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.